Investigator Contracts Lead 1

Posted 11 Days Ago
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Remote
Senior level
Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
We’re in relentless pursuit of breakthroughs that change patients’ lives.
The Role
The Investigator Contracts Lead is responsible for negotiating contracts and budgets with clinical investigator sites, overseeing the Per-Subject Cost process, and managing escalations related to budget issues. They collaborate with legal and finance teams, and lead the contracting activities while ensuring adherence to clinical trial timelines.
Summary Generated by Built In

JOB SUMMARY
Investigator Contracts Lead is responsible for direct site-facing contract and budget negotiations thought contract execution with assigned clinical investigator sites including initial agreements and amendments and oversight of other contracting professionals on assigned studies. This also includes managing the Per-Subject Cost (PSC) process for assigned studies, managing escalation and resolution for budget and non-legal term issues from other ICL or pCRO and collaborating with other lines to plan site contracting timelines though start-up.
JOB RESPONSIBILITIES

  • Exercise good judgment in balancing the risks for Pfizer in making budget and contractual decisions against the impacts to Pfizer clinical trial timelines.
  • Follow GPD processes to develop, negotiate, track and execute global clinical study agreements with institutions and investigators participating in sponsored clinical trials.
  • Work with partners to develop and oversee the global site budget process.
  • Work with clinical trial sites and directly negotiate cost, business and contractual terms and conditions with investigators/institutions, making changes to contract templates within the Legal division approved parameters.
  • Lead and develop relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interface.
  • Lead study level site contracting activities, direct other ICL and act as primary study point of contract for site contracting issues and timelines on assigned studies.
  • Partner with Legal and other divisions to manage escalations in the site budgeting and contracting space.
  • Partner with Legal, Finance, pCRO and other divisions to identify and implement areas of improvement in the site contracting space.
  • Has knowledge of the principles, concepts and theories in applicable business discipline.
  • Collaborates with invoicing specialists and/or invoice service provider to ensure alignment with Investigative Site contracting and compensation requirements.
  • Applies acquired job skills and procedures to complete substantive assignments, projects and tasks of moderate scope and complexity in applicable discipline.
  • Contributes to design, development and implementation of major business initiatives or special projects. Applies technical skills and discipline knowledge to contribute to the achievement of business objectives at GPD or WSR Functional Line level - e.g., WSR Worldwide Safety, WSR Worldwide Regulatory Operations, GPD Clinical Development & Operations, etc.


QUALIFICATIONS / SKILLS
Basic Qualifications:

  • 5+ years of experience in clinical development operations or clinical trial outsourcing and a bachelor's degree.
  • Experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities.
  • Balance of general business, compliance, finance, legal, and drug development experience.
  • Precise communications and presentation skills.
  • Ability to plan, identify and mitigate risks to site contacting timelines.
  • Demonstrated ability to lead by influence rather than positional power to accomplish critical deliverables.
  • Demonstrated success in working in a highly matrix-based organization.


Preferred Qualifications:

  • 2+ years of experience in clinical development operations or clinical trial outsourcing and a US Juris Doctorate or equivalent legal degree.
  • Experience in drafting and negotiating of Clinical Trial Agreements with clinical trial sites in a global operation.


Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let's start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Confident
We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!
Work Location Assignment: Remote - Field Based
At Pfizer we care about our colleagues' wellbeing and offer a range of great benefits for them, including:

  • Paid parental leave
  • Access to Health & Wellness apps
  • Career Growth Experiences program
  • Recognition & rewards program
  • Paid volunteer days
  • Life Insurance Benefits
  • Pfizer Learning Academy access to top content providers
  • Access to flu vaccines & skin checks
  • Options to purchase additional leave
  • Salary packaging & novated lease options


*Benefits listed may vary depending on your position and location and may be subject to change.
Pfizer Australia and New Zealand's diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies.
If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.
Global Procurement

The Company
HQ: New York, NY
121,990 Employees
Hybrid Workplace
Year Founded: 1848

What We Do

Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.

Why Work With Us

We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.

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